Kairos Pharma (KAPA) FDA Approvals $0.46 -0.02 (-3.87%) As of 03:10 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartEarningsFDA EventsNews and TrendsOwnershipSEC Filings Kairos Pharma's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Kairos Pharma (KAPA). Over the past two years, Kairos Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ENV-105. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. ENV-105 FDA Regulatory Events ENV-105 is a drug developed by Kairos Pharma for the following indication: in Metastatic Prostate Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Efficacy Data - October 6,2026Efficacy Data Phase 2Drug: ENV-105Announced Date: October 6, 2026Indication: in Metastatic Prostate CancerAnnouncementKairos Pharma, Ltd. announced positive interim efficacy data from its ongoing Phase 2 clinical trial evaluating ENV-105 (carotuximab) in combination with apalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC).Read Announcement Kairos Pharma FDA Events - Frequently Asked Questions Has Kairos Pharma received FDA approval? As of now, Kairos Pharma (KAPA) has not received any FDA approvals for its therapy in the last two years. What drugs has Kairos Pharma submitted to the FDA? In the past two years, Kairos Pharma (KAPA) has reported FDA regulatory activity for ENV-105. What is the most recent FDA event for Kairos Pharma? The most recent FDA-related event for Kairos Pharma occurred on October 6, 2026, involving ENV-105. The update was categorized as "Efficacy Data," with the company reporting: "Kairos Pharma, Ltd. announced positive interim efficacy data from its ongoing Phase 2 clinical trial evaluating ENV-105 (carotuximab) in combination with apalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC)." What conditions do Kairos Pharma's current drugs treat? Currently, Kairos Pharma has one therapy (ENV-105) targeting the following condition: in Metastatic Prostate Cancer. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events BioCryst Pharmaceuticals FDA EventsRezolute FDA EventsWAVE Life Sciences FDA EventsZai Lab FDA EventsMerck & Co., Inc. FDA EventsAltimmune FDA EventsPlus Therapeutics FDA EventsAlpha Tau Medical FDA EventsImmuneering FDA EventsMetaVia FDA EventsNeonc Technologies FDA EventsTraws Pharma FDA EventsTakeda Pharmaceutical FDA EventsBridgeBio Pharma FDA EventsCoherus Oncology FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Aprea Therapeutics FDA Events FibroBiologics FDA Events MetaVia FDA Events Alzamend Neuro FDA Events Alaunos Therapeutics FDA Events Soligenix FDA Events OSR FDA Events Liminatus Pharma FDA Events BioAtla FDA Events Ernexa Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NYSEAMERICAN:KAPA last updated on 10/6/2026 by MarketBeat.com Staff. 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Efficacy Data - October 6,2026Efficacy Data Phase 2Drug: ENV-105Announced Date: October 6, 2026Indication: in Metastatic Prostate CancerAnnouncementKairos Pharma, Ltd. announced positive interim efficacy data from its ongoing Phase 2 clinical trial evaluating ENV-105 (carotuximab) in combination with apalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC).Read Announcement
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